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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz Dual series computed Tomography Scanner System

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 Class 2 Recall
NeuViz Dual series computed Tomography Scanner System
see related information
Date Posted September 17, 2008
Recall Status1 Terminated on September 24, 2010
Recall Number Z-2307-2008
Recall Event ID 48727
Premarket Notification
510(K) Numbers
K062451  K071308 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product NeuViz Dual series computed Tomography Scanner System, X-Ray System
Code Information Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
Recalling Firm/
Manufacturer
Philips And Neusoft Medical Systems Co., Ltd.
16 Century Road, Neusoft Park,
Hun Nan Industrial Area
Shenyang, Liaoning
Consumer Instructions Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.
Manufacturer Reason
for Recall
Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components to be damaged inside the system gantry and for the internal components to be expelled from the system gantry and injure the patient, operator, bystander or service people.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On 6/23/08/08, the Philips Neusoft sent a letter dated 6/10/08 to their US customers explaining the problem, under what circumstances it can occur, and the actions that should be taken by the customer/user in order to prevent risks for patients or users. The field correction is install a R-host bracket to aid supporting of the R-host computer. The letter included additional information to customers who had already received the field action (this was an on-going activity that was re-classified as a potential safety). Customers did not receive the additional information about the status of their upgrade if the upgrade had not occurred at the time of the mailing. They were informed that they would be contacted by Newsoft Medical systems representative for the planning of this repair. If you have questions contact Service Support Department at nms-service@neusoft.com.
Quantity in Commerce 15 units in US
Distribution The units were distributed to one distributor in NC, and further distributed to medical facilities located in CO, FL, KY, NC, SC, TN and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = NEUSOFT MEDICAL SYSTEMS CO., LTD.
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